FDA 510(k)

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System

Número K: K230065 · 2023-05-26

Data da decisão2023-05-26

Código do produtoPNZ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230065. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System?

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Fiagon GmbH. The 510(k) number is K230065.

When did VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System receive FDA 510(k) clearance?

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230065.

Who is the listed applicant for VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System?

The FDA 510(k) record lists Fiagon GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System?

The FDA product code for VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System is PNZ.

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Outros registros que listam Fiagon GmbH como candidato(a)

K261540Cube 4D Navigation System, VirtuEye Pro K230700RIWOtrack Navigation System K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D K201472VenSure Balloon Device, VenSure Nav Balloon Device K200041FlexPointer 1.5 Single Use, FlexTube 3 Single Use K163209Fiagon Navigation System

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Fonte oficial

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